Often it is desirable to inspect the ear drum and the ear canal for evidence of infection, bulging, or simply for earwax which may plug the ear. In children foreign material such as cotton, tissue paper, or even small toy beads, for example, may be found to occlude the ear canal and thus necessitate removal.
Practitioners such as an ear, nose and throat (ENT) specialists routinely have specialized equipment such as binocular microscopes, head mirrors providing illumination, suction devices, irrigation, and other special devices at their disposal. Such devices are quite expensive, however, and may further require special skills for their use, or a second person to hold the patient's head during the procedure.
Practitioners have frequently carried out examinations of the ear canal with prior art otoscopes. If occluding matter was found, then the ear would be irrigated with warm water and other solvents. This dissolves or softens the occluding material to permit the removal thereof. Once the matter, such as wax, is softened by the irrigation fluid, it would often be removed manually with the aid of a metal curette having a head portion bowed to better fit the ear.
Examinations carried out in the foregoing manner using metal curettes could easily result in the abrasion of the tissues of the ear, especially when those tissues are wetted and softened by the irrigation fluid. Occasionally, even perforation of the ear drum could result. The risks involved in performing these procedures with equipment known in the art are even further increased when examining and treating small children. As is all too well known, children will cooperate minimally if at all, and are likely to become fearful and move about during the examination. Moreover, due to the noise and sensation of the curette within the ear, some children may develop vertigo and nausea during examination or treatment. Thus, these procedures are made quite complicated by the child's movements, and much time is required to complete the examination and the treatment.
The problems inherent in examining various sensitive orifices of the body have been recognized. Improved otoscopes and other ear cleaning devices have resulted. For example, U.S. Pat. No. 4,572,180 discloses a lighted ear canal curette instrument including a hand-held lighting member, a curette having an elongated handle and retaining members which telescopically receive both the handle member and the curette to secure the curette thereto. A magnification lens is hingedly attached to the lighting member to provide a view path as well as an optical path into the ear canal.
To avoid injuring the tissues of the ear, especially the ears of small children during the inspection and cleaning thereof, excellent visual access and support should be provided. This is especially important when the canal is made wet and particularly sensitive due to the softening effects of irrigating solutions or the like.
Below follows a brief synopsis of the most relevant prior art:
U.S. Pat No. 4,006,738 (1977) to Moore, et al. discloses the well known Welch Allyn, Inc. otoscope. It uses a halogen lamp positioned in the handle of the device. A bundle of optical fibers points the light into the viewing passage. Thus, there are no protuberances in the viewing passage.
U.S. Pat. No. 3,162,214 (1964) to Bazinet, Jr. discloses a bendable tube made up of a series of rings inside and outside of a tube. At least one pair of tensioning wires allows the tube to be bent by pulling on the periphery of the rings thereby compressing them. This device could conceivably be used for retraction, but it is more useful to house a fiber optics device. It is the closest art found. It does not teach a semi circular embodiment nor does it teach a combination with an otoscope. The cylindrical tube could not fit around a foreign body. It generally teaches a flexible cylindrical tube used for housing an instrument.
U.S. Pat. No. 3,799,151 (1974) to Fukaumi et al. discloses a fiber optic endoscope. A yieldably flexible main tube can be controllably bent by tensioning a pair of wires located in the opposite sides of the main tube. There is also a bendable tip portion having a second set of tensioning wires. In operation the doctor can choose to tension either or both sets of tensioning wires to bend the fiber optic tube to his choosing. Annular segments allow the controlled bending of the bendable tubes when the tensioning wires are tensioned. The tensioning of the wires shortens the length of the bendable tube. The annular segments allow a smooth bending of the bendable tube as the segments overlap. There is no teaching of retraction of foreign matter using this instrument.
U.S. Pat. No. 944,830 (1909) to Sussmann discloses a flexible gastroscope. A series of tubular links have peripheral channels for tensioning wires. Internal mirrors provide a viewing means.
U.S. Pat. No. 2,799,274 (1957) to Eisenhut discloses a veterinary evacuating probe. A pair of tensioning cables pass through the periphery of a series of articulating members. A magnet at the tip is used to detect and remove ferrous material from the stomach of a cow. Only movement in one plane is permitted.
U.S. Pat. No. 4,785,796 (1988) to Mattson discloses an otoscope with a flexible but not controllably bendable curette.
U.S. Pat. No. 4,572,180 (1986) to Deenadayalu discloses a lighted curette having a magnification lens.
U.S. Pat. No. 3,110,304 (1963) to Hartman discloses an ear speculum having a scooping spoon at the distal end. The spoon is manipulated to scoop out wax.
U.S. Pat. No. 5,133,721 (1992) to Angulo discloses an electric powered shape - memory - effect alloy used as a device for removing foreign objects. A wire tip of a curette bends either alone or in conjunction with a second member to form a tweezer. The device allows insertion of the tip past a foreign object and then the tip bends around the object for removal. The tip must then be manually bent back into shape. The device is a relatively costly device not suited for use as a disposable.
U.S. Pat. No. 4,198,960 (1980) to Utsugi discloses a foreign matter removal device having a sheath. The sheath houses a plurality of trapping wires forming a distal net. The wires are manipulated to snare the foreign matter.
U.S. Pat. No. 4,271,845 (1981) to Chikashige et al. discloses a bending device for medical instruments. A series of coarsely wound segments bend when a central tensioning wire is pulled. The device has a cylindrical cross section.
Of all the above inventions Hartman approaches the closest to an ideal solution. Hartman teaches a projection integrally formed on the distal end of a disposable plastic speculum. The projection is designed to remove the obstructing cerumen by rotational, hooking or scooping motion of the speculum, while the cerumen and the ear canal are under direct visual observation. The removal of cerumen under direct visual observation minimizes any risk of injury to the ear canal or tympanic membrane.
However, the problem persists of causing great discomfort in the patient by the rotational, hooking or scooping motion of the speculum. The speculum will rub against the ear canal with these motions. If infection or swelling exists, then the rubbing will cause great discomfort especially in children.
The present invention in its preferred embodiment improves on Hartman's invention by allowing the projection to be bent under the physician's control. Even more importantly the projection is shaped so as to fit between a foreign object and a body canal. The physician can bend the improved projection by using the index finger of the hand holding the otoscope. A mechanical linkage is made up of a control knob, a pair of guide filaments and a flexible projection. The flexible projection can controllably scrape the cerumen without moving the speculum. Alternatively the projection can be inserted past the cerumen or other foreign matter and then be bent and then extract the foreign matter. Thus, the patient discomfort is eliminated and the risk of causing patient movement is reduced considerably.